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8-week safety summary

The safety and tolerability of PERSERIS were studied in a Phase III, 8-week, randomized, double-blind, placebo-controlled clinical study.1,2

Adverse drug reactions (ADRs) occurring in ≥5%
of patients in PERSERIS clinical trials1
ADRs 90 mg (n=115)
%
120 mg (n=117)
%
Placebo (n=118)
%
Weight increased 13 13 3
Constipation 7 8 5
Sedation/somnolence 7 8 0
Pain in extremity 1 8 5
Anxiety 3 7 5
Back pain 4 7 4
Akathisia 3 7 4
Musculoskeletal pain 5 5 3
  • A typical increase in mean prolactin levels was observed for both doses of PERSERIS from baseline to end of study; mean prolactin for the placebo group remained stable during the study1
  • Extrapyramidal symptom (EPS)-related ADRs ≥2% were akathisia (90 mg: 3%; 120 mg: 7%; placebo: 4%), extrapyramidal disorder (90 mg: 4%; 120 mg: 2%; placebo: 1%), and dystonia (90 mg: 0%; 120 mg: 1%; placebo: 3%)1
  • There was no single adverse reaction leading to discontinuation that occurred at a rate of ≥2% (and greater than placebo) in PERSERIS-treated patients1
  • Mean weight of patients taking PERSERIS 90 mg and 120 mg increased by ≃10 pounds (4.4 kg) and ≃12 pounds (5.3 kg), respectively, from baseline to Day 57; mean weight of patients in the placebo arm increased ≃6 lbs (2.6 kg)1
    • Weight gain ≥7% from baseline occurred in 33% of patients in the 90-mg group, 42% in the 120-mg group, and 18% in the placebo group1

Longer-term safety and tolerability

An open-label, Phase III study (N=500) following an 8-week pivotal study evaluated the safety and tolerability of PERSERIS.2

Treatment-emergent adverse events (TEAEs) Overall, 11.6% of patients experienced TEAEs leading to study discontinuation.2 + -

Treatment-emergent adverse events (TEAEs) occurring in ≥5% of all patients2
TEAEs All patients (N=500) %
Weight increase 13
Schizophrenia 8
Insomnia 7
Akathisia 6
Upper respiratory tract infection 5
Headache 5
  • The most frequently occurring TEAEs leading to study discontinuation were schizophrenia (2.0%), weight increased (0.8%), and akathisia (0.8%)2

Adverse drug reactions (ADRs) The most commonly reported ADRs associated with EPS for all patients were akathisia (6%), tremor (2%), and extrapyramidal disorder (2%)2 + -

The most commonly reported ADRs leading to discontinuation2
ADRs All patients (N=500) %
Weight increase 1
Akathisia 1
Sedation/somnolence 1
Tremor 1
Galactorrhea 1
  • Mean weight of all patients receiving PERSERIS increased ~4 pounds (2 kg) from baseline to Day 85 and then remained stable for the remainder of the study1